France’s new 10-year cancer strategy and its implications on the rare disease space

By Erfan Akbraian, Analyst

Email: [email protected]

On World Cancer Day, 4^th February 2021, President Emmanuel Macron announced France’s 10-year Cancer plan¹. His predecessors have rolled out these strategies before, but they have been mid-term 5-year strategies. France has taken on board previous cancer plan insights and built an ambitious holistic 10-year strategy now. The plan involves a multi-stakeholder approach with patients, researchers, caregivers, hospitals, and public decision makers required to put the strategy into action. Patients are at the heart of it, as France wants to become a leader in prevention and has the ambition to become the driver within Europe to combat poor prognosis cancers, sequelae at 5 years after diagnosis, improve quality of life (QoL) of patients, improve access to innovation and access to treatment for all.

President Macron’s speech focused on all potential points of action to fight cancer. He explains that one of the main objectives of the cancer plan is to decrease the number of preventable cancers by 60,000 per year by acting on the prevention, especially the known risk factors such as diet, alcohol, environmental contamination, and tobacco. The cancer plan 2021-30 has taken into consideration that the cancer landscape is increasingly more fragmented due to more precise/personalised treatments for which smaller patient population are eligible. Over the coming years, the goals are likely to affect the rare disease space and the huge unmet need associated with rare disease drugs. There has been €1.7 billion set aside for the first 5 years of this strategic cancer plan to achieve the goals of the 4 key pillars.²

A summary of the 4 key pillars set out by the National Cancer Institute: ^3-4

1. Improve prevention
   • Strengthen cancer screening programs, develop new screening tests and promote personalised screening (currently in place for breast and colorectal (CRC) cancers but the objective in the plan is to start the national screening program for lung cancer)
   • Improve diagnosis to be more precise and less invasive
   • Adopt national programs and improve education of risk factors 
2. Limit the sequelae and improve QoL
   • Develop new clinical trial models to account for the safety of treatments to meet the challenges and improve QoL. With more emphasis on patient’s sequelae (due to disease and/or treatment) of 5 years post-diagnosis as well as the caregiver QoL
   • Develop accelerated assessment procedures and set up a national procedure for purchasing cancer drugs
   • Promote common training methods for caregiver and medical staff. Develop organisational and good practice recommendations for cancer diagnosis and treatment to reduce sequalae (prevention, screening, management)
3. Combat poor prognosis cancers
   • Encourage manufacturers to invest in ‘high risk-high gain’ clinical trials
   • Increased consideration for pain and palliative care
   • Establish networks of excellence and promote therapies with greater personalisation
4. Ensure progress benefits everyone
   • Fight against paediatric cancers and encourage manufacturers to develop medicines in this space as well as for cancers with dramatic prognosis or for sub-populations of cancer patients with high unmet need
   • Strengthen international data sharing and clinical practice in centres of excellence
   • Increase digital coordination between all key stakeholders

Associated milestones of the 10-year cancer strategy set by the National Cancer Institute: ⁵

1. To reduce the number of preventable cancers from 153,000 by 60,000 per year by 2040
2. To raise the current 9 million yearly screening tests to 10 million per year from 2025
3. To reduce from 2/3 to 1/3 the proportion of patients suffering from sequelae 5 years after a diagnosis
4. To significantly reduce the progression rate of cancers with poor prognosis by 2030

No specific details have been published on these proposed reforms and milestones; however, all key stakeholders are eagerly anticipating what these reforms will accomplish. Realistically, there will be operational gaps, with huge time and investment needed to mobilise and shape the key pillars. However, building experts networks and working in a multi-stakeholder approach will undoubtedly help.

The cancer plan is focusing on patients on all aspects from prevention, diagnosis, treatment, access, safety, toxicity, QoL, sequalae and even socio-economical aspects such as being able to work. However there has been a particular emphasis on bad prognostic cancers and a great deal of importance placed on QoL. The cancer plan identifies QoL data being as important as efficacy in the product assessment, possibly in the future there may be modifications made to measuring QoL and safety. However, it may be difficult for manufacturers to show survival or QoL benefit in these poor prognostic cancers. With the proposed modifications of fast tracking and funding cancer drugs, there may be more emphasis from French authorities to manufacturers to provide follow-up data and real-world evidence post-commercialisation for such poor prognostic cancers.

The proposed reforms are promising and could overcome some of the inefficiencies associated with the traditional pricing and market access (P&MA), by improving ways to track safety and QoL in clinical trials and by creating incentives to reward innovation associated with poor prognostic cancers. P4A will be observing how these proposed reforms will impact the P&MA space.

Sources:

1. https://www.elysee.fr/emmanuel-macron/2021/02/04/unis-pour-lutter-contre-les-cancers
2. https://www.lefigaro.fr/sciences/macron-lance-le-nouveau-plan-cancer-des-objectifs-sur-dix-ans-et-un-financement-en-hausse-20210204
3. https://www.e-cancer.fr/Strategie-Cancer/La-strategie-decennale-de-lutte-contre-les-cancers-2021-2030
4. https://www.e-cancer.fr/Institut-national-du-cancer/Strategie-de-lutte-contre-les-cancers-en-France/La-strategie-decennale-de-lutte-contre-les-cancers-2021-2030/Le-lancement-de-la-strategie
5. https://solidarites-sante.gouv.fr/actualites/presse/communiques-de-presse/article/la-france-se-dote-pour-la-premiere-fois-d-une-strategie-de-lutte-contre-les